E-beam and X-ray: Why? What? How? 1 Introduction & Agenda - PowerPoint PPT Presentation

E-beam and X-ray: Why? What? How? 1

Introduction & Agenda  Agenda:  We are investing to supply and service a growing market  E-Beam and X-ray are complementary solution that are financially viable  Mevex and IBA are there to help you to move from an idea to a real project  Still some challenges to adoption of E-beam and X-ray 2

WHY? Market Situation & Complication Today In-House  Complication : Service (~40%) (~60%)  Increasing pressure on Co60 (Price, Supply, Security, …) ETO (~60%)  Increasing pressure on EtO (Environmental, residual, …) Gamma (~35%)  Other (more specific): Product complexity, logistics, business model, … EB & XR (~5%) ~ 1,500 MCi 3

Market Situation in 10 years…? Today In 10 years In-House Service (~40%) (~60%)  Volume of EO and Gamma versus ? E-beam and X-ray? ETO (~60%) ?  Split between in-house and Service contractors? Gamma  Medical devices market growth ? (~35%) ?  Split between E-beam and X-ray? EB & XR ? (~5%) ~ 1,500 MCi ? 4

Market Situation in 10 years… What if … In 10 years What if, Only 40% in ETO, 25% in Gamma and 5% market growth?  35 % of 2,400MCi = 840MCi … ~ 280 systems of 3 MCi What if, Only 35% in ETO, 20% in Gamma and 7% market growth?  45 % of 3,000MCi = 1.350MCi … ~ 450 systems of 3 MCi What if, Only 30% in ETO, 30% in Gamma, 10% other modality and 5% market growth?  25 % of 2,400MCi = 600 MCi … ~ 200 systems of 3 MCi 200 to 400 systems over the next 10 years 5

EB and XR adoption is accelerating over the last 4Y Mevex and IBA Order Intake 5MeV+ for period of 2005-2015 and period of 2016-2019 - 6.5 MW over the last 15 years - 4 MW over the last 4 years - 2005-2015: Average of 4 Systems / year - 2016-2019: Average of 12+ Systems / year Build up the capacity – Resources & Technology 6

X-ray and E-beam are complementary technologies Different customer profile, with different products… Dose mapping Capex Capacity DUR Dose rate Capacity Cost ($/f³) flexibility In line Logistic Each case has a preferred configuration 7

Is X-ray viable? Many parameters to consider…  Some info:  Some question:  For Medical devices: For a 200 kW to 500 kW X-ray facility, Over a period of 10 years, what’s the impact on the cost per m³ of:  A CAPEX increase of $ 5M ? *8000h; 0,1$/kW  $2 to 3  A extension of the ramp-up period from 3 to 7 years?  $5 to 15  At 100kW Opex are spread as follow:  25% Elec, 55% Labor, 20% Others  An increase of the kW/h from 0.1 to 0.2?  $10 to 15  At 500kW Opex are spread as follow:  60% Elec, 25% Labor, 15% Others  Running the plant in 2 shifts instead of 3 shifts?  $15 to 35 8

X-ray versus Gamma – Is the Capex higher?  For a 5MCi equivalent 9

Hurdles to adoption  Real hurdles  Existing gamma infrastructure  Lack of x-ray infrastructure  Lack of experience within medical device companies  Perceived hurdles  Regulatory hurdles – standards already exist, FDA has pathways for transition  Experience with equipment - Daniken has been running 10 years, x-ray uses e-beam which has been in use decades more

Keys to success  Leverage existing infrastructure where possible  Ramp up machine source with decay  Leverage multiple modalities when possible  Use e-beam for efficiency  Use x-ray for products that can’t be treated in e-beam due to penetration  Compatibility needs to be established  X-ray will be gamma compatible 99.99% of the time  E-beam may have differences in material properties and heating

What is happening today  X-ray capacity is being built in Europe and North America  Multiple sites will allow for more adoption vs single source  More opportunities for product testing  Mevex and IBA are investing in new technologies and capacity in order to meet current and future demand for equipment  Risk is mitigated because high power solutions already exist or are built on existing platforms  Industry “ramp-up” requirement due to lack of cobalt availability is matched by Mevex and IBA capabilities

What are we doing as an industry?  Support collaborations like Team Nablo (IBA and Mevex both members)  Partnering with service providers to make more testing facilities/resources available  New guidance being written on transitions between radiation modalities through AAMI WG2  Follow up from Kilmer collaboration on Modality Changes and Process Optimization  Support for publications  Identify training gaps and opportunities  Provide support for FDA tools  FDA challenge to spur alternatives to EO

Conclusions  The market has spoken – e-beam and x-ray capacity is growing  There is a value proposition for each sterilization technology, but availability trumps economics in a supply constrained market  The transition is happening now – and we can all help to make it easier THANK YOU

Where can I learn more about e-beam and x-ray?  ASTM Dosimetry workshop, June 21-25 2020, Prague, CZ www.astm.org/E61_June_2020_Workshop  Texas A&M eBeam Workshop, College Station, TX ebeam-tamu.org/ebeam-workshop  Riso High Dose Reference Laboratory Course – Validation and Process Control for EB Sterilization, September 2019 www.nutech.dtu.dk/english/products-and-services/industrial-dosimetry/hdrl/hdrl_courses/  GEX training workshops – www.gexcorp.com  STERIS Education and Events www.steris-ast.com/education-and-events/  Sterigenics and Nelson Labs training sterigenics.com/events/,  IMRP (International Meeting on Radiation Processing), 2021 Bangkok, Thailand imrp-iia.com/  iia Membership/ website www.iiaglobal.com